Tag: lawsuit

UK pharma company removed work history at Purdue from Lewent’s biography

David Crow in New York 5 hours ago

A director of GlaxoSmithKline, the British pharmaceuticals company, has been sued by the state of Massachusetts for her alleged role in fuelling the US opioid addiction epidemic. Judy Lewent, who served on the board of opioid drugmaker Purdue Pharma for more than four years until 2014, was named as a defendant in a lawsuit filed by the state’s attorney-general last month. The legal action comes as US authorities step up their campaign against those they hold responsible for a crisis that resulted in 42,200 opioid overdose deaths in 2016. The litigation, described as a “ tidal wave” by experts, is designed to raise funds to cover the costs of the epidemic, including addiction treatment centres and expanded morgue capacity. The epidemic — which has been declared a “public health emergency” by Donald Trump — has attracted international attention, but GSK appears to have recently scrubbed all mention of Ms Lewent’s time on the Purdue board from its annual report and company website.

In the company’s 2016 annual report, Ms Lewent’s biography said she was “previously a non-executive director” of Purdue and an associated company until December 2014. But the 2017 report, released in March this year, omitted that reference. Screenshots from GSK’s annual report in 2016, left, and 2017: the reference (highlighted) to Ms Lewent’s connection to Purdue Pharma and associated groups was removed A similar change was made to the company’s website some time after November 2017, according to a preserved copy from The Internet Archive, a not-for profit group that maintains a library of historical webpages. A spokesperson for GSK said: “It is not appropriate for GSK to comment on legal matters faced by another company. Board biographies are updated and approved by directors during the routine annual report process. “Reference to Ms Lewent’s role as non-executive director of the private company Purdue Pharma, which ended on 31 December 2014, was disclosed in previous annual reports.”

Following the FT’s enquiries, the company said it would update its website so that Ms Lewent’s biography mentioned her tenure as a director of Purdue. Ms Lewent declined to comment via a GSK spokesperson and did not respond to direct enquiries. More than 30 US states, cities, counties and other local authorities have filed lawsuits against Purdue, a privately-held company that was among the biggest producers of opioid painkillers, as well as other drugmakers, wholesalers and pharmacy groups. Although most fatalities are caused by heroin spiked with fentanyl, a synthetic opioid, the majority of victims first became hooked on prescription painkillers like Purdue’s OxyContin before progressing to the illegal street drug.

However, the lawsuit filed in Massachusetts last month represented a new front in the legal fight because it targeted individual executives and directors of Purdue such as Ms Lewent and members of the wealthy Sackler family, which owns the company.

Ms Lewent, who is chair of GSK’s audit and risk committee, was paid $476,000 in fees by the British pharmaceutical company last year and $496,000 in 2016. A former chief financial officer at Merck & Co, the US drugmaker, she also serves as a director of Thermo Fisher Scientific and Motorola Solutions. OxyContin, made by Purdue Pharma, has been criticised for serving as a gateway to opioid addiction The legal complaint filed by Massachusetts alleges that Ms Lewent and the other defendants deceived patients and doctors on the risks of prescription opioids. It alleges that Purdue marketed the painkillers to vulnerable people, including the elderly, and encouraged physicians to prescribe them for long periods of time. Ms Lewent, who joined the Purdue board in 2009, and other directors were paid “hundreds of thousand of dollars” by the company, according to the lawsuit. The lawsuit says the directors were kept apprised of “signs that patients were being harmed” via regular reports, which “came in by the hundreds and even thousands”. Such reports were allegedly sent to Ms Lewent on eight occasions between April 2010 and July 2013.

A spokesperson for Purdue said it shared the attorney-general’s “concern about the opioid crisis”, but added: “We are disappointed, however, that in the midst of good-faith negotiations with many states, [Massachusetts] has decided to pursue a costly and protracted litigation process.” The spokesperson said the company “vigorously” denied the allegations and that it would continue to “work collaboratively with the states towards bringing meaningful solutions to address this public health challenge”. Purdue has not yet filed a response to the Massachusetts suit, but has filed motions to dismiss legal actions bought by other local authorities. One of its main lines of defence is that its medicines were approved by the US Food and Drug Administration for the treatment of chronic pain, which gave it the right to market them to doctors. “We believe it is inappropriate for [Massachusetts] to substitute its judgment for the judgment of the regulatory, scientific and medical experts at FDA,” said Purdue.

“..Afterwards you start thinking and looking back at your life, suddenly the penny fell: It is not my nature to be aggressive or anxious.” – Gerard Eggebeen

Gerard Eggebeen (32) used Seroxat for years. First prescribed it in his teens for depression, and then suffering serious side effects for years, he recently successfully sued GlaxoSmithKline and won.

The verdict of the judge only caused a brief moment of happiness. “Imagine the world as colorless, everything is gray and matt and nothing makes sense, that’s how I feel every day.” Gerard has little hope that he will ever get rid of his depression again. His struggle against the pharmaceutical giant keeps him going.

Mission

Since Gerard knows what damage seroxat has caused him, he sees it as his mission to get justice for himself and others.

“I will not rest before this mess is for everyone under eighteen of the market and people who have suffered from it experience a sense of justice,” he says. “The idea that someone is sitting somewhere in a skyscraper at GSK, who now knows what they have done to people…”

See these articles in Dutch (use google translate to get an ok gist of it in English) for more:

A trial is currently underway in Illinois as a widow seeks to hold pharmaceutical manufacturer GlaxoSmithKline accountable for improper labeling and minimizing a potentially serious side effect of a well-known antidepressant.

Paroxetine is a widely prescribed antidepressant and anti-anxiety drug under the class of drugs known as selective serotonin reuptake inhibitors (SSRIs). Paroxetine is most commonly known as the brand name of Paxil, manufactured by GlaxoSmithKline (GSK).

Since 2012, Wendy Dolin has been engaged in a legal battle against GSK following the suicide of her husband, Stewart Dolin. Wendy says that in the summer of 2010, Stewart was prescribed a generic version of Paxil for anxiety issues related to work. According to Wendy, Stewart Dolin complained of becoming increasingly anxious and restless and was unable to sleep while taking the drug. On July 15, 2010, less than one week after beginning this medication, Stewart committed suicide by walking in front of a train.

Wendy began searching for answers in the wake of her husband’s suicide and said she learned that he had been displaying signs of akathisia, a disorder characterized by an individual’s inability to relax or sit still. Psychiatrist Joseph Glenmullen said in 2006 that “Patients have described [akathisia] to me as listening to nails scratching on a black board 24/7, or your bones rattling like tuning forks. It is this inner agitation that is by far the most dangerous.” In 2012, Wendy filed a legal complaint against GSK seeking to hold the manufacturer liable for her husband’s death. The complaint noted that “a scientist working for another SSRI manufacturer, Pfizer, wrote in a 1998 medical journal article that the suicidal impulses resulting from akathisia may be explained as a feeling that ‘death is a welcome result’ when the ‘acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.’”

The critical issue in Wendy Dolin’s lawsuit is not simply paroxetine itself. It’s no secret that lawsuits against pharmaceutical companies are usually complicated under most circumstances, but this case is particularly notable as a tragic example of the gray area of liability when a patient is prescribed a generic drug, as well as the problems between the FDA and drugmakers that exist when it comes to publishing safety labels for patients and doctors.

It’s important to distinguish that Stewart Dolin was not prescribed the brand of Paxil, but a generic brand of paroxetine that was manufactured by another company, Mylan. Brent Wisner, Wendy Dolin’s attorney, described the issue as a “donut hole of liability” in which both the generic and the original manufacturer deny responsibility. “That’s where you have the generic maker on one hand saying, ‘We don’t know about these risks. We can’t be held responsible for them… plus, we can’t change the label,’” Wisner said according to an NBC investigative report. Winner added that “the brand name makers are saying, ‘Well, we didn’t make the pill.’”

Generic drugs are often prescribed in place of specific brands, mainly to save costs, as generic drugs cost far less than brand names on average. In Illinois, where the Dolin family resided, “state pharmaceutical laws actually require such a substitution unless a doctor has advised against it. Some of the few courts that have sided with plaintiffs in generic-drug injury cases have also highlighted this conundrum for generic-drug plaintiffs,” according to a Law360 report on Wendy’s case.

Wendy and Wisner claim that the warning label that was given to the generic brand was “factually incorrect and misleading.” In their lawsuit, they allege that “the paroxetine label in existence at the time of Stewart Dolin’s death did not warn of the drug’s association with an increased risk of suicidal behavior in adults despite GSK’s knowledge of a statistically significant 6.7 times greater risk in adults of all ages. In fact, the label stated the opposite – that the suicidality risk did not extend beyond the age of 24.” Stewart Dolin was close to 57 when taking paroxetine.

The lawsuit alleges that GSK whitewashed the suicide risks of Paxil in its data given to the FDA. The complaint explains that in 1989, GSK”s “Integrated Summary of Safety Information,” required to gain approval from the FDA, included a presentation identifying the number of suicide and suicide attempts during clinical trials. The suit alleges that GSK’s summary “skewed the statistical analysis of the data presented and obscured the true risk” by including suicide attempts “of placebo patients that had taken place in the placebo run-in (or wash-out) phase” before the clinical trials began. “Run-in” or “wash-out” refers to a time period of removing any other drugs in a trial participant’s system; any “adverse events” that take place during those periods are not appropriate or generally accepted for inclusion in calculations during clinical trials, the suit claims.

The Cook County Record reports that while those warning labels on Paxil and paroxetine were approved by the FDA, GSK said it was not allowed by the FDA to include an additional warning of a “statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine.” GSK claims that the FDA wanted to maintain homogeneous warnings among all antidepressants.

However, U.S. District Judge James Zagel noted that GSK “never asked for a formal meeting, nor did it seek additional labeling regarding Paxil-specific data” in a February 2016 ruling, and further wrote that “Moreover, GSK never sent a separate supplement and declined the FDA’s invitation for a meeting to discuss the inclusion of … the adult warnings.”

The trial against GSK is in progress and is expected to last a few weeks. Bob Fiddaman, a blogger and author who has written extensively about his own experiences with paroxetine, has been covering the developments of the trial. Fiddaman wrote that a “startling revelation” was unveiled on March 22nd:

Attorneys representing widow Wendy Dolin showed the ratio of Paxil-induced suicidality in adults is a staggering 8.9. It is not 6.7, as previously claimed and reported by Glaxo. The 6.7 figure is astoundingly high in itself, but the 8.9 ratio is flabbergasting!

Plaintiff witness, Dr. David Ross, said this figure is ‘astounding.’ What you should remember here is that GSK’s 1989 drug application for Paxil said the suicidality odds ratio was 2.6.

Fiddaman wrote that Dr. Ross, who worked for the FDA for ten years, offered lengthy testimony. Fiddaman points out that Dr. Ross discussed the problematic relationship between the FDA and drug manufacturers. The FDA relies heavily on the accuracy of the data that is provided by drug companies, which is problematic when the companies present arguable data.

GSK’s argument has summarily been that they do not bear liability because the drug that was prescribed to Stewart Dolin was not manufactured by Mylan, not GSK. The company has stated that “we remain consistent in our stance that since GSK did not manufacture or market the generic paroxetine ingested by Mr. Dolin, it should not be held liable in this trial.”

Sunday, November 20, 2016

ChinaWhys Vs GSK – The Claims – Part 2

Following on from the first parter, Lawsuit Alleges GSK’s Witty Lied to the Media – Part I, today sees part 2 (The claims of ChinaWhys against GSK) – Part 3 (Coming later this week) will focus on the incarceration of Peter Humphrey and his wife, Yu Yinzeng and also the rehiring of accused whistleblower, Vivian Shi)

Here is what Peter Humphrey and his wife, Yu Yinzeng, of ChinaWhys, are alleging…

– Between 2010-2013 GSK spent nearly $225 million on planning and travel services. Approx 44% of the sampled invoices were inflated and approximately 12% were for events that did not occur. – GSK set up a special “crisis management” team in order to bribe a Chinese regulators with money and gifts. A GSK executive attempted to bribe a Chinese investigator with an IPad and a lavish dinner. All bribes were approved by the head of Chinese operations, Mark Reilly. – GSK planned to suppress evidence of its illegal bribery activities. – As far back as 2008, GSK China deliberately falsified its books and records in order to conceal its illegal practices in China. These included, bribery and promotion of drugs for purposes that have not been approved by the Chinese authorities. – GSK paid a patient RMB 50,000, who nearly died after being given Lamictal off-label. Despite having knowledge of Lamictal caussing near death in this patient, GSK still told its reps to promote the use of Lamictal for off-label purposes. – GSK targeted ‘persuasive doctors’ in attempts to influence purchasing descions at their hospitals. GSK are to said to have forged a connection with these doctors by taking them to expensive lunches and dinners and also giving them gifts and cash. – GSK paid between 500 and 1,000 doctors to go on an all-expenses paid holiday to locations such as Brazil, India, Israel, Greece, Japan and Hungary. GSK covered all costs, including cash to cover meals and sight-seeing excursions. These were disgusied by GSK as “Conference trips.” – Head of Chinese operations, Mark Reilly, reeived a bribe in the form of ‘sexual relations’ in return for passing business on to China Comfort Travel, a travel agency who organised ‘conference sevices’ for GSK. – GSK paid doctors based on their prescription numbers. – GSK’s senior legal counsel, Jennifer Huang, asked private investigator, Peter Humphrey, to investigate the Public Security Bureau and to prepare an analysis of the Chinese political regime. Huang told Humphrey that she wanted to find out who’s who regarding the team who were investigating GSK. – Humphrey became concerned that GSK were trying to obstruct the investigation and declined to investigate state secrets. – Humphrey was also asked, by GSK, to look into the Ministry of Public Security, the Economic Crimes Investigation Department regarding the relationship between them and the Public Security Bureau. Humphrey, once again, declined. – Head of Chinese operations, Mark Reilly, told Humphrey that the alleged whistleblower, Vivian Shi was “coming after him.” (Humphrey). Reilly then fled China the following day. – GSK China told its employees to “destroy all non-compliant promtional maeterials and gifts.” They also implemented a new email system and deleted emails that were more than a year old. They claimed this was to “reduce unnecessarily legal costs.”

Thursday, November 17, 2016

Lawsuit Alleges GSK’s Witty Lied to the Media – Part I

A 42 page complaint was filed on November 15, 2016, by Peter Humphrey and his wife, Yu Yingzeng, in relation to GSK’s nefarious activities in China which saw the pair incarcerated for around 2 years in Chinese slum-like conditions prison cells.

The complaint delves deep into the whole sordid affair and alleges bribery on a huge scale, more importantly, the complaint alleges that GSK hired the services of Humphrey and Yu in efforts to smokescreen the corruption in China, corruption, according to the complaint, that they had known about for many years. Furthermore, the 42 page document alleges that GSK’s CEO, Andrew Witty, lied to the media when he was asked about the corruption in China.

Humphrey and Yingzeng were the founders of ChinaWhys, a professional-services consultancy that specializes in discreet risk mitigation solutions, consulting and investigation services to corporate clients in matters of high sensitivity across Greater China and the Asia Pacific.

On April 15, 2013, Humphrey met with GSK’s Head of Chinese operations, Mark Reilly, April Zhao, GSK China legal counsel and Brian Cahill, also GSK legal counsel. It was at this meeting that Humphrey was told that GSK had been sent a series of emails from a whistleblower alleging widespread corruption – GSK told Humphrey that they believed they knew who the whistleblower was.

Vivian Shi had previously worked for GSK as a government affairs director, GSK had terminated her services with them in December 2012. According to the complaint GSK claimed that Shi had orchestrated a “smear campaign” against GSK involving a total of 23 emails that had been sent to Chinese officials throughout the country, a letter had also been sent to GSK’s ‘top management’ alleging widespread corruption in GSK’s pharmaceutical and vaccine business that had been approved by GSK China’s senior management.

These were allegations brought to Humphreys attention just months after GSK had been fined a record breaking $3 billion by the Department of Justice in America – the fine was handed down after a guilty plea by GSK who, after the settlement, entered into a five-year Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services. The agreement requires enhanced accountability, increased transparency and wide- ranging monitoring activities conducted by both internal and independent external reviewers.

One month after meeting with GSK officials Humphrey was told that GSK’s global CEO, Andrew Witty, had been made aware that GSK had been using a travel agent to channel kickback to customers and doctors throughout China. Days after Witty had been made aware, the whistleblower also sent a video to him and other senior management that showed GSK China’s Mark Reilly engaged in sexual activity – Reilly later claimed that the woman in the video was his “regular girlfriend”.

GSK officials told Humphrey that they had launched their own internal inquiry regarding the whistleblower allegation and that they were false. They told Humphrey, “There is nothing there”. This, according to the complaint, was a lie.

Humphrey and his wife offered to investigate the whistleblower allegations but GSK declined the offer, opting instead for Humphrey to investigate Vivian Shi, the woman they believed was the whistleblower.

Two months after Humphrey and Yu started their background search of Vivian Shi, GSK received another letter from the whistleblower alleging that GSK China continues to engage in systematic bribery of doctors, this email focused on GSK China’s botox business whereby the whistleblower claimed that…

GSK had a ‘pay to prescribe’ scheme that funneled money through a central source at Beijing Medical College whereby ‘lecture fee payments’ were made to doctors who could “…incentivize and reward doctors for prescribing Botox.”

At no point did GSK show either Humphrey or Yu this letter.

On June 12, 2013, the Wall Street Journal (WSJ) ran an article highlighting GSK China’s massive bribery network. In July of that year 4 senior GSK China executives were arrested and, according to Humphrey’s filed complaint, GSK CEO, Andrew Witty told the worlds media that “…it appears that certain senior executives in the Chinese business have acted outside of our processes and our controls to both defraud the company and Chinese healthcare system.” Witty also claimed that GSK’s Head office in London lacked knowledge of the whistleblower allegations and “had no sense of this issue.”

According to the complaint, this made no sense as since the previous month GSK did, indeed, “have a sense” of the issue since it announced its 4 month internal investigation into allegations of bribery and corruption in China and found “No evidence of corruption or bribery.”

The complaint states…

Witty argued, nonsensically, that the previous whistleblower allegations were “quite different” from the more recent charges, saying, “they are two completely different sets of issues, we fully investigated the first and, of course, this has now surfaced in the last couple of weeks.”

This was a lie, since “what surfaced” in the PSB investigation and raids of GSK offices in July was precisely the illegal activity that the whistleblower had documented and threatened to reveal in January.

The complaint was filed in The United States District Court for the Eastern District of Pennsylvania.

Humphrey and Yu are represented by Boies, Schiller & Flexner LLP

**Coming in Part 2**
– A full and comprehensive list of the allegations made by Peter Humphrey and Yu.
– GSK ask Humphrey to ‘overtly’ obstruct the Chinese government investigation.
– Evidence, including emails, to be destroyed as not to implicate any wrong-doing by the company.Bob FiddamanBack stories.Glaxo – The Sex Tape Scandal

GlaxoSmithKline to face class action over anti-depressant used on children

Date
March 11, 2016 – 9:37PM

Bianca Hall
Bianca Hall
Legal Affairs Reporter for The Age

Paroxetine was once the most commonly used anti-depressant in Australia.

A Sydney law firm has launched a class action on behalf of people who as children and adolescents were prescribed the anti-depressant drug Paroxetine.

Drayton Sher Lawyers has called for expressions of interest from people who were prescribed the drug, commonly known as Aropax in Australia, when they were 18 or younger.

Solicitor Tony Nikolic​ said hundreds of people had indicated they would join the class action, which he expects to file in the Federal Court at the end of May.

Paroxetine was a commonly-prescribed anti-depressant more than a decade ago and for a time was the most commonly used anti-depressant in Australia.
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In 2001, GlaxoSmithKline (then SmithKline Beecham) funded a randomised trial of the drug that showed Paroxetine was safe for use in adolescents.

But concerns about its use persisted. In 2004 the Therapeutic Goods Administration’s Adverse Drug Reactions Advisory Committee said there was international concern about the risk of increased suicidal ideation and self-harm among children and adolescents using Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants.

“It should be noted that none of the SSRIs is approved for the treatment of MDD [major depressive disorder] in children or adolescents in Australia, but these drugs are being used for this purpose.”

A team led by the University of Adelaide’s Professor Jon Jureidini re-examined the GlaxoSmithKline research last year and found there were “quite striking” rises in the suicidal thoughts experienced by those taking the drug compared with those taking a placebo.

The review team found that 11 people who took the drug in 2001 experienced experienced suicidal thoughts or behaviours, compared with one person who took the placebo.

Mr Nikolic said one person joining the class action had been prescribed Paroxetine as a six-year-old, and soon began having suicidal thoughts.

“Now, if someone is assisted by this, fine. But they know that these things have suicidal thoughts or ideations attached to them.”

Mr Nikolic is calling for anyone who was, as a minor, prescribed Paroxetine – which also traded under a number of generic names including Chemmart Paroxetine, Extine, GenRx Paroxetine, Paroxetine Actavis and Terry White Chemists Paroxetine – to come forward if they experienced side effects.

These side effects could include suicidal feelings, attempted suicide, and causing others an injury.

A former GlaxoSmithKline biostatistics manager has filed a whistleblower lawsuit accusing the drug maker of firing him for alleging dodgy study data was used to tout the effectiveness of a smoking-cessation product.

Alexandre Selmani, who worked at Glaxo for nearly a decade, claims his supervisors ignored repeated efforts to alert them to statistical mistakes made in clinical trials for NiQuitin, according to the lawsuit, which was filed in a New Jersey state court. In the United States, Glaxo markets the product as Nicoderm.

As a result, he claims the company engaged in an “illegal, deceptive marketing program” to promote the product “without justification” as a “significant advance” in nicotine treatment. The lawsuit also alleges Glaxo maintained its product was superior to existing nicotine treatments.

Selmani began complaining about the data in mid-2012. But after meeting resistance, he claims to have sent an email to Glaxo Chief Executive Andrew Witty to warn that the mistakes had “the capacity to cause negative consequences and potential health and safety issues for the general public,” the lawsuit argues, although it does not allege any consumers were harmed.

Along with the drug maker, the lawsuit also names Witty and several employees as defendants. A Glaxo spokeswoman declined to comment.

Despite his protests, the company submitted the data for publication and the study was eventually published online in Psychopharmacology in April 2014. The study abstract concluded the product “could be useful to provide quick craving relief for low-dependence smokers.”

In his suit, Selmani maintains that his supervisors retaliated against him by giving him low job performance ratings and reduced raises; sabotaging some of his work; and, ultimately, firing him last October. His lawsuit cites the New Jersey Conscientious Employee Protection Act, which addresses retaliation by employers.

“The company wanted to use flawed data to sell the product to the public,” Rosemarie Arnold, his attorney, told us. “And when he brought that to the attention of his supervisor, he was basically told to shut up. He worked there many years, got great reviews, and did a great job. But they tried to push him out when he complained they used improper data. And consumers paid for something they didn’t get.”

According to the lawsuit, Selmani’s supervisor told him that he was wasting his time to report the mistakes because he would never be able to convince management to fix them. At one point, Selmani was also told that his “future was not with GSK.”

Law360, New York (March 04, 2014, 5:06 PM ET) — In a groundbreaking ruling Friday, an Illinois federal judge determined that GlaxoSmithKline PLC can be held liable for a Reed Smith LLP corporate and securities partner’s suicide even though he took a generic version of the antidepressant Paxil, not the brand-name version made by the company.
The decision contradicts dozens of court rulings nationwide that brand-name drugmakers cannot be held liable for an injury caused by a generic drug. Only a handful of courts, including the Alabama Supreme Court, a California state appeals court and a Vermont federal court, have held otherwise.

The case appears to be the first time a court in the Seventh Circuit has considered the issue, according to the opinion by U.S. District Judge James Zagel.

The suit concerns the 2010 suicide of Stewart Dolin, the onetime chairman of Reed Smith’s corporate and securities group. Six days after he began taking paroxetine hydrochloride, a generic version of Paxil, to treat work-related anxiety and depression, he left his Chicago office and killed himself by jumping in front of an “L” train.

Dolin’s wife Wendy sued GSK and the manufacturer of the generic drug he took, Mylan Inc., claiming they failed to warn patients that adult users of paroxetine were at greater risk of suicidal behavior.

Judge Zagel dismissed Mylan from the suit but granted only part of GSK’s motion for summary judgment. While GSK cannot be held strictly liable for Dolin’s suicide, the company can be found negligent, he said.

The judge rejected GSK’s contention that the negligence claims were product liability claims in disguise, saying Illinois law did not require him to construe one as the other.

“The injury here did indeed occur in connection with a product. And GSK manufactures products. Yet plaintiff has not brought suit against GSK for tortious conduct committed strictly as a manufacturer of products. And, though GSK implicitly urges to the contrary, I see no reason why all suits brought against GSK must be brought against GSK qua manufacturer,” he said.

In order to determine whether a defendant owes a duty to a plaintiff even if they are not directly connected, Illinois courts are supposed to consider four factors, Judge Zagel said: the reasonable foreseeability of an injury, the injury’s likelihood, the burden of guarding against the injury and the consequences of putting that burden on the defendant.

The factors indicate GSK owed a duty to Dolin, according to the judge. GSK should have expected generics manufacturers would make paroxetine once the patent for Paxil expired, and it knew the companies would have to follow GSK’s label for the drug, he said. GSK failed to show that the likelihood of an injury was so remote that it eliminated its duty of care, he said.

To guard against the risk of suicide by someone like Dolin, GSK could have simply changed its warning label, Judge Zabel said. There is a danger of overwarning about a risk, but GSK did not argue that the danger outweighed the duty it owed to Dolin, he said.

“That GSK did not manufacture the pill Mr. Dolin ingested is largely immaterial on this point,” the judge said. “GSK will not be tasked with the burden of crafting one new warning label for Paxil, and then other discrete warnings for various generic iterations of the drug — that all of the iterations of paroxetine are bioequivalent and require the same warning is precisely the point.”

GSK “has been compensated for taking responsibility for paroxetine’s design and warning label” through the Hatch-Waxman Act, which extended brand-name makers’ exclusivity over sales of their drugs, according to Judge Zabel.

“If you create a drug and know that it poses serious risks, regardless of whether consumers use the brand-name or generic version of that drug, you have a duty to warn,” Wisner said in a statement.

GSK criticized the ruling, saying that nearly 90 other decisions, including all six federal appeals court decisions to date, have rejected brand-name maker liability for generic-drug injuries.

“Holding a branded manufacturer liable for its generic competitor’s product forces the branded manufacturer into the role of an insurer for the generic industry … [s]uch a result would chill research and innovation,” the drugmaker said in a statement.

A Reed Smith representative declined comment on the ruling, saying the case was not a firm matter. Reed Smith has represented GSK in other product liability matters.

Judge Zagel dismissed Mylan from the suit based on the U.S. Supreme Court‘s landmark Bartlett ruling last year, in which it held that federal law preempts design defect claims against generic-drug makers.

Thousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US.

The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.

A scientist with the Food and Drug Administration estimated that Avandia could have been responsible for 100,000 heart attacks in the US.

The manufacturer, GlaxoSmithKline, has admitted concealing data about the damaging side-effects of the drug, and there is evidence of the drug’s harmful effects. But, despite this, GSK is not prepared to settle claims in the UK without a court fight.

The history of drug litigation in the UK suggests that families might not easily get compensation.

Daniel Slade, with the Express company of solicitors in Manchester, has 19 cases on his books and has begun proceedings against GSK in four of them.

The pharmaceutical firm has told the solicitors that it will contest the cases. In just one of the cases it has indicated a willingness to spend £600,000 on its defence, which, the solicitor says, would be a fraction of what the claim is worth.

“It is very disappointing,” said Slade. “We anticipate that these claims do have a good prospect of success, but they still have to prove their case in the UK with suitable evidence. They are tasked with having to produce that evidence, including medical expert opinion. It is a burden one would have thought they might not have to go through.”

He expected that, if GSK fought in the courts rather than settled outside, as it had done in the US, it would take years for bereaved relatives, or those who have been harmed, to get any sort of payment.

A spokesman for GSK said: “We have every sympathy for people with complications associated with diabetes and those who care for them, but unfortunately we are unable to comment on individual legal cases. We continue to believe that the company acted appropriately and responsibly in its management of Avandia.”

Liz Thomas, policy manager at the patient safety charity Action against Medical Accidents, said it had “become increasingly difficult in the UK to challenge large corporations such as pharmaceutical companies, an incredibly expensive form of litigation”.

Corporations have a vast amount of money at their disposal to contest legal cases, but legal aid is about to cease for medical negligence cases.

The Avandia cases in Manchester will be fought on a “no win, no fee” basis by Express solicitors.

The cases in the US were settled by GSK extremely quickly, said Thomas. “I would hope they would not take advantage [in Britain] of the inequality of arms.”

Avandia was first introduced in the NHS in July 2000. It was given to people with type 2 diabetes whose glucose levels were no longer being properly controlled by the standard drugs – metformin and a sulphonylurea drug. Avandia could be prescribed with those drugs or on its own.

The drug, which generically is known as rosiglitazone, was designed to lessen the body’s resistance to insulin. It was available as a standalone drug – Avandia – or in a combination with metformin, and known as Avandamet.

When both drugs were withdrawn by the European Medicines Agency, there were about 90,000 people taking them in the UK.

The first warnings of trouble with Avandia came in 2007, when a prominent US scientist, Steve Nissen, published data from a review of 42 clinical trials which had been carried out on the drug. The trials involved 28,000 patients, and showed that Avandia could cause heart attacks. Further trials, the results of which were published in 2010, found people on Avandia were 27% more likely to have a stroke, 25% more likely to have heart failure, and 14% more likely to die, than patients on an alternative diabetes drug.

Potentially yet more damaging for GSK was its guilty plea to federal charges of concealing data about the drug’s side effects. Most of the data on the drug comes from GSK’s own trials. In November 2011 GSK agreed to pay $3bn to the US government over the Avandia issue and to end investigations into its marketing of the antidepressants Paxil (Seroxat in the UK) and Wellbutrin.

“This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today,” Andrew Witty, chief executive of GlaxoSmithKline, said at the time.

GSK is also still defending cases in the UK from people who claim to have been badly affected by Seroxat. A group action, involving people who say they suffered severe withdrawal problems when they tried to stop the drug, has been going on for years though many claims have been settled in the US.

The same is true of Vioxx, made by Merck, the painkiller that was withdrawn after it emerged eight years ago that it doubled the risk of a heart attack.

Diabetes drug causes death and now they want another pill approved

Spirit Happy has reported on the shady practices of Glaxo Smith Kline for many years. As far back as 2008 we reported that their drug Avandia would cause heart attacks and that is exactly what the drug did. Unfortunately this has not stopped them from seeking another Billion dollar profit drug for diabetes. They refuse to stop making diabetic drugs because it profits them over 4 Billion dollars a year.

Here is their History in Diabetes drugs

Glaxo was ordered to pay 90 million dollars in the Unites States for the heart attacks and deaths related to their drug Avandia. We warned the public but few listened back in 2009, we told the public that very few people need a drug Type 2 diabetes, it can be reversed naturally. We informed the public that Avandia, Actos, and other high blood sugar medications were all dangerous drugs that destroyed the heart valve. The drug maker simply lie and they do it because the billions are too great a temptation for them. They simply want the money at any cost, even death to the person taking the drugs.

90 million is a low settlement seeing as the drug profited over 5 Billion dollars each year for 5 years. Each family victimized is reported to receive 53 thousand dollars. In addition the drug maker makes much more money on stocks once the drugs receive approval. When a diabetic drug is approved the company’s stocks fly up because it means millions in straight profit. This is the billion dollar big money game in pharmaceutical drugs.

The story about Glaxo gets sicker as they were also found guilty of fraud, a 9 year investigation showed that the company lied to the public and hide information that the diabetes drug and other drugs they made were dangerous. They bribed doctors to promote their drugs. Did you know doctors get cash and vacations for prescribing a certain number of drugs? Glaxo sales reps lied and told doctors that the drug Avandia would even help the heart( while the drug really causes heart attacks) Drug companies have sales people who push the drugs on the doctors( Legal street drugs are not the only dirty drug game, prescription drugs may be more dirty)

Glaxo salesmen get commissions( $) based on how many doctors they can get to prescribe the drug

Glaxo was found guilty of hiding the heart attack risks from the FDA.

Glaxo moved the dirty operation and had the drugss made in factories in Puerto Rico to save tax dollars. What a shame.

These are the things they were found guilty of, this is not just an opinion, they admitted lying and hiding the truth and they pleaded guilty to all the charges above.

In total Glaxo has paid back the largest suit in US drug history 5 billion dollars, yet Glaxo profited over 20 billion dollars in 5 years from the diabetes drug

The drug business is a dirty business operated for huge profits.

In an amazing development Glaxo filed to the FDA to have a new diabetes drug approved and they have been approved last week!

The USA reported the story

GSK Diabetes Drug Receives FDA Approval As Initial Therapy

and here is the statement for Glaxo’s spokesperson

“GlaxoSmithKline is committed to developing diabetes therapies to treat a disease that has reached epidemic proportions in the United States and throughout the world,” said Anne Phillips, vice president of Clinical for North America Cardiovascular-Metabolic at GSK,

What hypocrisy, they have admitted lying and defrauding the diabetic yet they say they are committed to helping the diabetic. . They caused deaths which no settlement could ever make up for. Glaxo stocks went up 1.6 % after the settlement and the stockholders were said to be “happy” that they did not lose their investments in the company.

Diabetes for them is a stock market game with billions dollar of dollars at stake. Their executives make more money than the average person will ever see. Ask your doctor if type 2 diabetes can be reversed without drugs and he will inform you that it can. The drugs are part of a billion dollar con game.

“Responding to a news article in The Guardian this morning (Jan. 30) on UK legal proceedings related to our type 2 diabetes medicine Avandia (rosiglitazone), we would like to make the following points:

“We have every sympathy for people with health complications associated with diabetes and those who care for them. However, respecting the UK court process, we are unable to comment on ongoing legal cases

“.We continue to believe that the company acted appropriately and responsibly in its management of Avandia.

“Specifically, it is wrong to suggest that we hid or concealed safety data relating to Avandia.

“We made Avandia clinical trial results available on our website and shared these with regulators.

“With respect to Avandia, the settlement reached in 2012 following a US Department of Justice investigation related solely to the inadvertent omissions in certain Food and Drug Administration (FDA) regulatory reports of information regarding the initiation and status of certain studies.

“The Department of Justice has expressly acknowledged that the information had been provided by GSK to the FDA in other forms. The FDA has also stated that the omissions did not impact the agency’s evaluation of the safety data related to Avandia.

“We continue to stand behind the safety and efficacy profile of Avandia in the treatment of type 2 diabetes when used appropriately.

“Nevertheless, we fully accept regulators’ decisions to restrict its use and have worked to make sure health professionals and patients understand this latest advice and guidance.”

The Offense

GSK’s response came after The Guardian reported that the company faces a number of lawsuits in the U.K. over Avandia.

“We expect the number of claims to increase as there are potentially thousands of people out there who took Avandia in the U.K.,” a lawyer told the newspaer. “Hopefully these claims will lead to more careful studies and checks on drugs that are widely marketed.”

GSK has said it paid more than $3 billion to settle U.S. federal and state government claims that it illegally marketed Avandia, once the world’s best-selling diabetes pill, and other medications. According to estimates by Bloomberg news service, individual Avandia settlements in the U.S. will be around $57,000.

“It is very disappointing,” the attorney said of GSK’s decision to fight. “We anticipate that these claims do have a good prospect of success, but they still have to prove their case in the UK with suitable evidence. They are tasked with having to produce that evidence, including medical expert opinion. It is a burden one would have thought they might not have to go through.”

If GSK leaders believed the Avandia settlements in the U.S. would make the nightmare go away, they obviously were mistaken.

GSK going public with a response to The Guardian shows the firm remains very sensitive to criticism about the drug and its handling. If court fights begin in public across the U.K., watch out …